A Multicenter, Prospective, Randomized Controlled Clinical Study on the Effect of Hysteroscopic Uterine Septum Resection on IVF-ET Outcomes in Infertile Patients With Non-recurrent Miscarriage

Summary

This study aims to evaluate the impact of hysteroscopic transcervical resection of the septum (TCRS) on fertility in infertile women without recurrent miscarriage, primarily assessing its effect on subsequent IVF-ET outcomes. The research attempts to answer: for infertile women with uterine septum planning to undergo IVF/ICSI (excluding preimplantation genetic diagnosis), does TCRS improve pregnancy outcomes (such as live birth rate, pregnancy rate, miscarriage rate, etc.) compared to non-surgical treatment (conservative observation), and to clarify the clinical value and safety of this surgical intervention.

Conditions

• Infertility and Miscarriage

Interventions

PROCEDURE

Transcervical resection of septum

Hysteroscopic surgery is divided into two categories: one is plasma hysteroscopic electrosurgical resection (actually TCIS), which uniformly uses a 7mm external diameter hysteroscopic electrosurgical resectoscope to reduce the difficulty of cervical dilation; the other is micro (5 or 7Fr) hysteroscopic cold knife incision, equipped with a 5Fr bipolar electrocoagulation stick for electrocoagulation and hemostasis.

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• Maternal and Child Health Hospital of Hubei Province

  collaborator OTHER

• The First People's Hospital of Yunnan

  collaborator OTHER

• Tianjin Medical University General Hospital

  collaborator OTHER

• Guangzhou First People's Hospital

  collaborator OTHER

• Gansu Maternal and Child Health Hospital

  collaborator UNKNOWN

• Hospital for Reproductive Medicine Affiliated to Shandong University

  collaborator UNKNOWN

• Women's Hospital School Of Medicine Zhejiang University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Beijing Tiantan Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• Beijing Fuxing Hospital

  collaborator UNKNOWN

• The Third Xiangya Hospital of Central South University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-01

Primary Completion

2027-12-31

Completion

2030-06-01

Countries

• China

Study Locations